Efficacy and safety of the Chinese herbal medicine Xiao'er Niuhuang antipyretic plaster for treating fever in children with acute upper respiratory tract infection with wind-heat syndrome: a multicenter, randomized, double-blind, controlled clinical trial.

OBJECTIVE

To evaluate the efficacy and safety of Xiao'er Niuhuang antipyretic plaster in treating fever associated with acute upper respiratory tract infection (AURI) accompanied by wind-heat syndrome in children.

METHODS

A total of 464 pediatric patients diagnosed with AURI and wind-heat syndrome were enrolled. Participants were stratified into two age subgroups (1-2 years and 3-5 years) and then randomly assigned in a 3:1 ratio to receive either the Xiao'er Niuhuang antipyretic plaster or an extremely low-dose control plaster. The primary outcome was the time to onset of fever reduction. Safety assessments included monitoring of vital signs, laboratory tests (complete blood count, urinalysis, stool routine, and liver and kidney function), electrocardiogram, and local skin reactions.

RESULTS

The median time to onset of antipyretic effect was significantly shorter in the Xiao'er Niuhuang antipyretic plaster group than in the control group (2.53 h vs 3.98 h). The complete antipyretic rates at the 4-h time point were 31.76% for the Xiao'er Niuhuang antipyretic plaster group and 17.70% for the control group; at the 8-h time point, the rates were 49.55% and 33.04%, respectively. No significant difference was observed in the incidence of adverse events between the two groups (P >0.05). No serious adverse events were reported.

CONCLUSION

Xiao'er Niuhuang antipyretic plaster is an effective and safe treatment for fever in children with AURI and wind-heat syndrome.